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Ultra Surgical Masks

by Crosstex International Inc EUDAMEDGUDID

Active European Union

Ref GCFCXSModel Face Masks and Shields

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0732224FaceMask&ShieldQM Basic UDI-DIDate8 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10732224120017 UDI-DIDate11 Nov 2016ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Ultra Surgical Masks EUDAMED
UltraTM Earloop Mask GUDID
Generic Name
Surgical/medical respirator, non-antimicrobial, single-use
Model / Ref / Catalog
Face Masks and Shields, GCFCXS
Primary DI / UDI-DI
10732224120017
Basic UDI-DI
0732224FaceMask&ShieldQM
Unit of Use DI
00732224120010
FDA Product Code
FXX
EMDN Code
T020604 Medical use face masks, type II and iir
GMDN Term
Surgical/medical respirator, non-antimicrobial, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
878.4040
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000009642
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Crosstex International, Inc.

See all devices from Crosstex International, Inc. →

Properties

  • Single Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No